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Free E-newsletter Subscribe to Housecall . The identity of the study drug was revealed only if the subject experienced a medical emergency the management of which would be improved by the knowledge of the blinded treatment assignment.As the combination therapy of Bilastine + Montelukast consisted of two tablets in contrast to monotherapy with either Bilastine or Montelukast, the double-dummy technique was applied with matching placebo for each Investigation Medicinal Product (IMP) (monotherapy with Bilastine or Montelukast) to ensure the maintenance of double-blind conditions. The SKY study.
The antihistamine, i.e. Mild to moderate asthma was defined according to the criteria of the Global Initiative for Asthma, i.e., GINA criteria 2 and 3 (GINA, 2012).
In sensitive patients the simultaneous administration of cetirizine or Levocetirizine and alcohol or other CNS depressants may have effects on the central nervous system, although it has been shown that the racemate cetirizine does not potentiate the effect of alcohol.
Corresponding Author.
Federico Lavorini. You have reached the maximum number of saved studies (100).Please remove one or more studies before adding more.The purpose of this study is to compare concomitant administration of Montelukast and Bilastine to Montelukast and Bilastine monotherapies in patients with SARC and asthmaThe present study (SKY) was designed to show if once daily oral combination therapy with Montelukast 10 mg and Bilastine 20 mg is superior to monotherapy with Bilastine 20 mg in patients with Seasonal Allergic RhinoConjunctivitis (SARC) and comorbid mild to moderate asthma on total symptom scores (TSS) and if the combination therapy reflects an improvement in quality of life as assessed via the Asthma Quality of Life Questionnaire (AQLQ) over a longer time period when compared to monotherapies with Montelukast 10 mg and Bilastine 20 mg.
Moreover, since changes in lung function were not monitored, it is difficult to gauge how far this improvement reflected possible effects of study treatments on bronchoconstriction and/or lower airways inflammation or how far they reflected a true placebo effect. Federico Lavorini. Development Timeline for Bilastine E-mail address:
[email protected].
Bilastine is an investigational selective histamine H1 receptor antagonist for the treatment of allergic rhinitis.In January 2008, Inspire Pharmaceuticals, Inc. announced the termination of the licensing agreement with FAES Farma, S.A. and the cessation of the development and commercialization of bilastine.Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.Gavreto (pralsetinib) is an oral selective RET kinase inhibitor for the...Detectnet (copper Cu 64 dotatate) is a radioactive diagnostic agent indicated...Onureg (azacitidine) is a nucleoside metabolic inhibitor indicated for the...Qdolo (tramadol hydrochloride) is an opioid agonist indicated in adults for ...The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The reason(s) for not showing any additive effects of bilastine plus montelukast compared with each agent alone could be likely related to the overall mild intensity of SARC symptoms at baseline that might have reduced the room for improvement thus limiting the probability to detect differences between treatments.